In healthcare industry, ensuring the safety, efficacy, and quality of pharmaceutical products is a critical requirement. At ITC Labs, we offer comprehensive pharmaceutical testing services designed to meet stringent regulatory requirements and industry standards. Our pharmaceutical testing labs are equipped with advanced technology and methodologies to deliver reliable and accurate testing solutions for drugs testing and pharmaceutical product testing.
Comprehensive Pharmaceutical Testing Services
Our pharmaceutical analysis lab specialises in testing drug products and active pharmaceutical ingredients (APIs) to ensure compliance with national and international regulations.
We conduct a wide range of pharmaceutical analysis testing, including:
1. Dissolution, HPLC & Assay Testing
Our testing services are open to a wide spectrum of applications:
Dissolution Testing
Determines the rate at which a drug dissolves in a solution, crucial for bioavailability studies
High-Performance Liquid Chromatography (HPLC)
Used for related substance analysis, assay, and dissolution studies to ensure product purity and stability.
Liquid Chromatography with Mass Spectroscopy (LC-MS/MS)
Advanced method for identifying and quantifying impurities, including Nitrosamine impurities.
We perform the following Nitrosamine tests at our labs:
- N-Nitrosodimethylamine (NDMA)
- N-Nitrosodiethylamine (NDEA)
- N-Nitrosodibutylamine (NDBA)
- N-Nitrosodiisopropylamine (NDIPA)
- N-Nitrosomethylpropylamine (NMPA)
- N-Nitrosoisopropylethylamine (NEIPA)
- N-Nitrosomethylaminobutyric acid (NMBA)
- N-NitrosoDiclofenac
- 1-Methyl-4-Nitrosopiperazine (NMPIPZ)
- N-Nitrosodorzolamide
- N-Methyl-N-Nitrosopiperazine (NMPP)
- N-Nitrosopiperidine
- N-Nitrosopyrrolidine
- N-Nitromethylethylamine (NMEA)
- N-Nitroso Aceclofenac
2. Impurity Profiling & Residual Solvents Analysis
Impurity profiling is a critical part of pharmaceutical product testing to detect unwanted chemical substances that could affect drug safety. We offer:
Organic Impurities Testing:
- Residual solvents analysis using Gas Chromatography (GC-MS/MS).
- Identification and quantification of Nitrosamine impurities
Elemental Impurities Testing
- ICP-MS (Inductively Coupled Plasma Mass Spectrometry)
- ICP-OES (Inductively Coupled Plasma Optical Emission Spectrometry)
- AAS (Atomic Absorption Spectroscopy)
- IC (Ion-Exchange Chromatography)
3. Particle Size Analysis
Particle size distribution affects the dissolution rate, bioavailability, and stability of pharmaceutical products. Using Particle Size Analyzer-3000, we provide precise particle size analysis to ensure formulation consistency.
4. Extractable & Leachable Studies
Contaminants from packaging materials and production equipment can migrate into drug formulations. Our pharma testing services include:
- Chemical Analysis
- Elemental Impurities Testing
- Organic & Non-Organic Impurities Analysis
5. Microbiological Testing for Contamination & Pathogens
Microbial contamination can compromise drug safety. Our pharmaceutical testing lab offers comprehensive microbiology testing, including:
- Microbial Limit Test
- Bacterial Endotoxin Test
- Preservative Efficacy Testing
- Disinfectant Efficacy Test
- Sterility Testing
- Vitamin B12 Assay
- Antimicrobial & Antibiotic Assay
- Environmental Monitoring
- Growth Promotion Testing
- Microbial Kill Rate Study
- In-use Stability Studies
6. Compliance with Pharmacopoeia Standards
Our pharmaceutical analysis lab ensures compliance with national and international pharmacopoeias, including:
- Indian Pharmacopoeia (IP)
- United States Pharmacopoeia (USP)
- European Pharmacopoeia (EP)
- British Pharmacopoeia (BP)
- International guidelines for Nitrosamines detection and control
Why Choose ITC Labs for Druga & Pharmaceutical Testing?
At ITC Labs, we take pride in offering top-tier pharmaceutical testing services backed by cutting-edge technology and a team of experts dedicated to quality and compliance. Our commitment to excellence makes us a trusted pharmaceutical testing lab for businesses across the industry. We leverage advanced analytical instruments such as HPLC, GC-MS/MS, ICP-MS, and LC-MS/MS to ensure precise and accurate testing results. These technologies help in detecting impurities, ensuring drug stability, and meeting stringent regulatory requirements, making us a reliable partner for pharmaceutical product testing.
We offer a full spectrum of testing services, from drugs testing to pharmaceutical product testing, covering everything from impurity profiling to microbiological analysis (redirect to microbiology page). Our pharmaceutical analysis lab provides end-to-end solutions to help manufacturers maintain the highest standards of quality and safety.
Our team of experienced scientists and analysts is committed to delivering high-quality pharmaceutical testing services with precision and reliability. Their expertise ensures that every test meets industry standards, providing manufacturers with confidence in their product quality.
With a focus on accuracy, compliance, and innovation, ITC Labs is the preferred choice for pharma testing services. Contact us today to learn more about how we can support your pharmaceutical testing needs.
We offer a full spectrum of testing services, from drugs testing to pharmaceutical product testing, covering everything from impurity profiling to microbiological analysis (redirect to microbiology page). Our pharmaceutical analysis lab provides end-to-end solutions to help manufacturers maintain the highest standards of quality and safety.
Our team of experienced scientists and analysts is committed to delivering high-quality pharmaceutical testing services with precision and reliability. Their expertise ensures that every test meets industry standards, providing manufacturers with confidence in their product quality.
With a focus on accuracy, compliance, and innovation, ITC Labs is the preferred choice for pharma testing services. Contact us today to learn more about how we can support your pharmaceutical testing needs.
FAQ
ITC Labs tests a wide range of pharmaceutical products, including raw materials, active pharmaceutical ingredients (APIs), bulk drugs, and finished drug products. Our services cover various dosage forms and therapeutic categories.
We adhere to international pharmacopeial standards and guidelines, including those from the USP, EP, and ICH. Our laboratory is equipped with advanced instrumentation, and our staff is trained to perform tests in compliance with these standards.
Nitrosamine impurities are potential carcinogens that can be present in pharmaceutical products. Testing for these impurities is crucial to ensure product safety and regulatory compliance.
Yes, we provide tailored testing services to meet the specific needs of our clients. Our team works closely with clients to develop and validate methods suitable for their unique requirements.
You can request a quote by contacting us through our website (redirect to contact us page) or reaching out to us via call or mail. Our team will reach out to you to understand your testing needs and provide a detailed quote.